Comparison of the Efficacy of Duloxetine and Pregabalin in Patients With Knee Osteoarthritis With Mix Type Pain

Fatih Sultan Mehmet Training and Research Hospital

Status and phase: Completed; Phase 4

Conditions: Knee Osteoarthritis

Treatments: Drug: Duloxetine; Drug: Pregabalin

Study type: Interventional

Funder types: Other

Identifiers

NCT04532684

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Details and patient eligibility

About

Osteoarthritis (OA) is a common degenerative joint disorder associated with chronic pain at older age.It is known that patients with osteoarthritis experience nociceptive and neuropathic pain to varying degrees. Addition of molecules targeting neuropathic pain to conventional therapy has been shown to improve treatment response in the management of osteoarthritis.The aim of our study is to evaluate the effect of duloxetine and pregabalin on pain, functional capacity, quality of life, depression, anxiety and sleep patterns in knee osteoarthritis.

Full description

A total of 66 patients (aged 40-69) with knee osteoarthritis were randomized into two treatment groups to receive either duloxetine 60mg/day or pregabalin 300mg/day. The patients were evaluated before and one month after treatment and three months after treatment using the visual analog scale (VAS-pain), Neuropathic Pain Diagnostic Questionnaire (DN4), Short Form-36 (SF-36) Questionnaire, Western Ontario and McMaster University Osteoarthritis İndeks (WOMAC), Beck Depression Scale (BDS), Beck Anxiety Akalası (BAS), Pittsburg Sleep Quality Index (PSQI).

Enrollment: 66 patients

Sex: All

Ages: 40 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 40-69
• Diagnosed with knee osteoarthritis according to the American College of Rheumatology (ACR) criteria
• Grade 2-3 knee osteoarthritis according to Kellgren-Lawrence grading system
• VAS-pain score: 4 and above
• Neuropathic Pain Diagnostic Questionnaire (DN4) score: 4 and above
• Body mass index value: 40 and below

Exclusion criteria

• A history of trauma or surgical operation in the knee region
• Diabetes mellitus
• Fibromyalgia
• Inflammatory rheumatic disease
• Central or peripheral neurological disorder
• Severe cardiac, pulmonary, or malignant disease
• Invasive treatment for knee last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

Duloxetine

Active Comparator group

Description:

33 patients received 60 mg/day of duloxetine HCL orally for 12 weeks

Treatment:

Drug: Duloxetine

Pregabalin

Active Comparator group

Description:

33 patients received 300 mg/day of pregabalin orally for 12 weeks

Treatment:

Drug: Pregabalin